Today, NAVREF submitted formal comments to the U.S. Food and Drug Administration (FDA) regarding the draft guidance “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance marks an important step in addressing the underrepresentation of diverse populations in clinical trials, which will ultimately improve the safety and effectiveness of medical products for all patients, including veterans.

NAVREF’s response highlighted the unique role the VA’s research programs can play in helping sponsors meet the FDA’s new diversity requirements. The VA serves a highly diverse population of veterans, including individuals from various racial, ethnic, and socioeconomic backgrounds. This diversity offers an unparalleled opportunity for medical product sponsors to conduct inclusive clinical trials that reflect the demographics of patients who will use these products in real-world settings.

Read our comments here: NAVREF FDA Comments